IVFNCT06551376
LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START IN IVF
A study testing Ovarian Stimulation Start in people with IVF, run by Clinia de fertilización Asistida en el Hospital ABC.
Trial summary
To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- Ovarian Stimulation Start
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled
Who cannot join
- Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: IVF CYCLE SCHEDULING WITH LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START TO AVOID WEEKENDS RETRIEVALS: PROOF OF CONCEPT
To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.
Read the detailed description
Objective To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.
Design Multicentric prospective non-randomized study
Setting Two university-affiliated private assisted reproduction centers.
Patient(s) Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled. Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria.
Intervention(s) Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses; similarly, twenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day.
Main Outcome Measure(s) Primary outcome: number of mature oocytes retrieved. Secondary outcomes: fertilization rate, viable embryo rate per oocyte retrieved, cancellation rate, and clinical pregnancy outcomes from FET cycles.
- Conditions
- IVF
- Being tested
- Ovarian Stimulation Start
- Keywords
- Ovarian Stimulation, luteal phase start, early follicular phase start, ovarian response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian Stimulation StartOther
To compare ovarian response accordin to ovarian stimualtion start
| Study group | Role | What they receive |
|---|---|---|
| Early Follicular Phase ovarian stimulation | Placebo comparator | Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses Receives: Other: Ovarian Stimulation Start |
| Late Luteal Phase ovarian stimulation | Active comparator | Twenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day. Receives: Other: Ovarian Stimulation Start |
What is being measured
The primary outcome is the main question the study is designed to answer.
mature oocytes retrieved
Measured: At retrieval
Secondary outcomes (3)
fertilization rate
Measured: 24 hours after retrieval
viable embryo rate per oocyte retrieved
Measured: 5 days after retrieval
cancellation rate
Measured: 14 days after cycle start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinia de fertilización Asistida en el Hospital ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551376
- Sponsor's protocol ID
- NPI010924
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF CYCLE SCHEDULING WITH LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START TO AVOID WEEKENDS RETRIEVALS: PROOF OF CONCEPT
- ClinicalTrials.gov ID
- NCT06551376
- Acronym / sponsor ID
- NPI010924
- Conditions
- IVF
- Keywords
- Ovarian Stimulation, luteal phase start, early follicular phase start, ovarian response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinia de fertilización Asistida en el Hospital ABCUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.
Detailed description
Objective To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.
Design Multicentric prospective non-randomized study
Setting Two university-affiliated private assisted reproduction centers.
Patient(s) Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled. Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria.
Intervention(s) Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses; similarly, twenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day.
Main Outcome Measure(s) Primary outcome: number of mature oocytes retrieved. Secondary outcomes: fertilization rate, viable embryo rate per oocyte retrieved, cancellation rate, and clinical pregnancy outcomes from FET cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Follicular Phase ovarian stimulation | Placebo comparator | Other: Ovarian Stimulation StartTwenty patients started controlled ovarian stimulation (COS) after spontaneous menses |
| Late Luteal Phase ovarian stimulation | Active comparator | Other: Ovarian Stimulation StartTwenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled
Key exclusion criteria (1 listed)
- Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian Stimulation StartTo compare ovarian response accordin to ovarian stimualtion start | Other | Early Follicular Phase ovarian stimulation, Late Luteal Phase ovarian stimulation |
Primary outcome
mature oocytes retrieved
Time frame: At retrieval
3 secondary outcomes
fertilization rate
Time frame: 24 hours after retrieval
viable embryo rate per oocyte retrieved
Time frame: 5 days after retrieval
cancellation rate
Time frame: 14 days after cycle start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian Stimulation Start in people with IVF, run by Clinia de fertilización Asistida en el Hospital ABC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Rodriguez-Purata, MD (55 4246 9686, jorge@ovulsans.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mature oocytes retrieved (time frame: At retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.